February 2023


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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health
Ilan Kirsch Adaptive Biotechnologies Corp.

regulatory science
Isaac Rodriguez-Chavez Independent Consultant

Patient engagement
Chi Pakarinen MediPaCe
Thomas Smith Independent Patient Consultant

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Sandra Blumenrath, Managing Editor, Scientific Publications DIA Scientific Communications

Chris M. Slawecki, Senior Digital Copyeditor DIA Scientific Communications

Regional Editors

David Mukanga Bill and Melinda Gates Foundation

Jin Shun Sandoz

Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Julie O’Brien Pfizer

J. Vijay Venkatraman Oviya MedSafe

Ozawa Goshi Real Discovery Outdoors Co,. Ltd.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Considerations for Sponsors as They Prepare for FDA’s Diversity Plan Requirements
Dylan Bechtle
Dinorah Villanueva
Janssen Research and Development

otential differences among racial and ethnic groups in the metabolism, effectiveness, and side-effect profiles of novel investigational medicinal products (IMPs) underscore the need to enroll participants from diverse populations into clinical trials. If medical care is not tailored to all who need it, certain categories of patients will be left behind. Regulators have realized this, and sponsors must be prepared to comply with new regulatory expectations. This article addresses the proactive steps sponsors can take to prepare for the submission of clinical trial diversity plans to regulators, and more specifically the US FDA.

Patient Engagement That Enables Regulatory Decisions
Co-Creating Next Steps in Patient-Focused Drug Development
Magda Chlebus
Nicholas Brooke
The Synergist
Juan García Burgos
European Medicines Agency
Sharon Gorman
Annette Bakker
Children’s Tumor Foundation Europe
Almath Spooner

egulators’ expectations of patient involvement in drug development are growing, while new tools are helping to remove practical barriers to working with patients. A multistakeholder group is co-creating a repository of resources that can accelerate progress ahead of the DIA Europe 2023 DIAmond Session on 24 March 2023. The road ahead is clear; only the speed of progress is in doubt.

Around the Globe: Africa
Drug Development and Clinical Research in Africa
Part 1: Reversing the Impact of Omitting More than One Billion People from Global Research
Lisa Ursella Collins
Innomas Clinical Research
Leslie Sam
Leslie Sam and Associates
Jayesh Pandit
Patient Safety Advocate, Kenya
Helen Ndagije
Uganda National Drug Authority
Wangui Mathenge
International Society of Pharmacovigilance Africa Chapter

n 2010, the Deloitte Life Sciences and Healthcare Industry Group collaborated with the Economist Intelligence Unit on a white paper addressing the future of the life sciences industries after the 2008 and 2009 global recession. With feedback from senior executives, C-level executives, and board members, this paper highlighted the growing importance of emerging markets. China, India, Brazil, Russia, Mexico, and Turkey were identified as these emerging markets, but not a single African country.

Around the Globe: Africa
Drug Development and Clinical Research in Africa
Part 2: African Clinical Trials, Good Clinical Practice, and Diversity: Practical Challenges and Considerations
Lisa Ursella Collins
Innomas Clinical Research
Leslie Sam
Leslie Sam and Associates
Jayesh Pandit
Patient Safety Advocate, Kenya
Helen Ndagije
Uganda National Drug Authority
Wangui Mathenge
International Society of Pharmacovigilance Africa Chapter

oth experienced and aspiring research professionals with an interest in participating in more global drug development and clinical research activities are keen to see an increase in the contribution of African countries to global research programs and in the increased arsenal of interventions that could potentially increase treatment options for their patients.

Around the Globe: Africa
Drug Development and Clinical Research in Africa
Part 3: Drug Development from Africa to the World
Lisa Ursella Collins
Innomas Clinical Research
Leslie Sam
Leslie Sam and Associates
Jayesh Pandit
Patient Safety Advocate, Kenya
Helen Ndagije
Uganda National Drug Authority
Wangui Mathenge
International Society of Pharmacovigilance Africa Chapter

he life sciences industry must engage with the many key opinion leaders and subject matter experts across the African continent who offer deep technical and scientific knowledge about their patient populations, standards of care, health systems, challenges, strengths, and cultural particularities and priorities. The inclusion of more African countries in global clinical trials brings both concerns and hopes for researchers across the continent.

White Paper

 The Pharma Technology Playbook

White Paper

Salesforce: The Pharma Technology Playbook
Pharmaceutical companies must continue to drive innovation even in the face of enormous challenges. From increased pressure in drug pricing to reimbursement constraints to the competitive nature of biosimilar products, success depends on a company’s ability to stay agile, increase efficiencies, and do more with less—all while continuing to improve the consumer experience. Learn how an integrated health and life sciences platform can power innovation, drive internal efficiencies, and help deliver the kinds of experiences patients and consumers have come to expect.
Key Wins for Patients in GPP Update
Angela Sykes
Catherine Skobe
Trishna Bharadia

ew, updated Good Publication Practice Guidelines for Company-Sponsored Biomedical Research (GPP) published by the GPP Steering Committee in September 2022 aimed at supporting publication of company-sponsored biomedical research and includes important new topics such as working effectively with patients.

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Meeting Highlights: DIA China Annual Meeting 2022
China’s NMPA Takes Action to Participate in PIC/S
DIA 2022
Fang Zhou
Harbour BioMed

ince initiating the process of pre-admission to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in September 2021, the National Medical Products Administration (NMPA) has been actively taking part in PIC/S-related activities in preparation to become a PIC/S participating authority. To foster better understanding of and promote GMP regulation harmonization and inspection conformance across countries, a PIC/S workshop was held during the DIA China 2022 Annual Meeting. As an exchange of mutual experience in support of China to join PIC/S, these discussions (summarized below) covered the latest regulatory considerations and requirements to ensure product quality and patient safety from various perspectives.

Meeting Highlights: DIA China Annual Meeting 2022
China Applications for Clinical Trials and Drug Registration Must Now Be Electronic
Highlights and Impact
DIA 2022
Handsome Ji
Pfizer China R&D Center
Wen Yin
Pfizer China R&D Center

ffective January 1, 2023, in accordance with the requirements of the NMPA Announcement (No. 110, 2022) on the Implementation of Electronic Submission for Drug Registration (Chinese only) released on November 30, 2022, all regulatory submissions for clinical trial applications, new drug applications, and all supplementary dossiers thereto must be submitted in electronic format. Applicants may no longer submit any paper documentation.

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Around the Globe: India
Synergy between Pharmacovigilance and Medical Writing to Benefit Patients
Arunima Sen Dey

o many casual observers, pharmacovigilance (PV) and medical writing (MW) can appear as two disconnected pieces in the drug development lifecycle. In many organizations, PV and MW are two different functions, working in two different silos. Different terminology between these two fields doesn’t do much to correct this perception.

Around the Globe: Japan
Next-Generation Medical Infrastructure Law in Japan
Appropriate Use of Individual Medical Information
Yumi Wakabayashi
Janssen Pharmaceutical K.K.
Takahiro Horimatsu
Institute for Advancement of Clinical and Translational Science, Kyoto University
Hiroshi Asai
Astellas Pharma, Inc.
Yasuhiro Himeno
Cabinet Office, Government of Japan
Hiroyuki Taruno
Cancer Institute Hospital, Japanese Foundation for Cancer Research

he Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field (commonly known as the “Next-Generation Medical Infrastructure Law” [hereafter, NGMIL]) is a law enacted in May 2017 in Japan. Its purpose is to achieve both protection of personal information and promotion of the use of medical information/data, aiming to develop economic society and improve public health. It came into force in May 2018. But progress has been slow, and more cooperation is needed among different stakeholders to implement it in full. The NGMIL Supplementary Rules state: “At the time when 5 years have passed after the enforcement of the Act, the implementation status shall be examined, and measures shall be taken as necessary.” A working group for this purpose has already been established and started, and 2023 is the opportune time to discuss NGMIL.

Around the Globe: US
Digital Endpoints in Clinical Trials Need Pre-Competitive Collaboration
What’s the (End)Point in Digital Health Technology?
Diana Rofail
Michelle Crouthamel
Pip Griffiths
Lucy Cesnakova
Jennifer C. Goldsack
Digital Medicine Society

he use of technology in clinical trials has increased dramatically. Although technology is now used at all levels of the process, from molecule discovery, trial logistics, and participant selection, clinical trial endpoint measurement is also gaining traction, with substantial growth in recent years. In fact, 378 unique digital endpoints are currently being used by 104 sponsors across a wide range of therapeutic areas. But some challenges still stand in the way of fully describing digital endpoints and measures in drug labeling.

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Thanks for reading our February 2023 Issue!
Views and opinions expressed in Global Forum are those of the authors alone and do not necessarily represent those of DIA or any other agency, organization, employer, or company. DIA does not guarantee the accuracy or completeness of any information published in Global Forum and will not be responsible for any errors, omissions, or claims for damages, including exemplary damages, arising out of use, inability to use, or with regard to the accuracy or sufficiency of the information contained in Global Forum.